Patient Safety Put at Risk from Contaminated Medical Devices

Main Category: Medical Devices / Diagnostics
Article Date: 17 Mar 2005 - 11:00 PDT

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GS1 UK calls for action following revealing Patient's Association report -

Findings from a Patient's Association survey about the tracking of medical devices in Britain's hospitals and the implications for patient safety published earlier this week should not be ignored, GS1 UK, the UK authority for cross-sector supply chain standards, warned key healthcare decision makers today. The report, which questioned staff working in theatre and sterile services departments, raises grave concerns about the quality of medical instrument decontamination, the ability to know if a device goes missing, and calls for improved tracking systems in the name of patient safety.

According to the survey:

-- 97 per cent of respondents said that the new generation of off-site sterile service decontamination "super centres" need to have tracking and tracing systems for individual medical devices

-- 78 per cent of respondents felt that patient safety would be improved by better tracking and tracing

-- One third (39 per cent) of respondents reported it would be impossible to track a single instrument back to an individual patient

-- 24 per cent of respondents from theatre departments did not feel confident that the medical devices used in theatre were decontaminated properly

-- In sterile services the level of concern about the decontamination of equipment was lower at 10 per cent. This can be attributed to a higher use of automated tracking and tracing systems, such as bar coding and radio frequency identification (RFID) than in other departments - at almost 50 per cent

GS1 UK underlines the Patient's Association's call for an urgent need for hospitals to track individual surgical instruments. This will allow greater visibility of medical devices and therefore give confidence that cleaning procedures have been followed, equipment can be identified and patient safety can be guaranteed. GS1 UK urges the Department of Health to consider the mandatory adoption of automated systems such as has been deployed at the Royal Free Hampstead NHS Trust, one of the largest acute London Trusts.

By individually marking its inventory of surgical instruments, bar code technology helps Royal Free Hampstead NHS Trust to manage its clinical risk with Scantrack's track and trace application - IMS. The Trust saw drastic improvements in the ability to trace items; there was a complete verification of the decontamination and sterilisation process, and a reduction in surgery delay due to the unavailability of instruments.

Jim Brown, Decontamination Manager and Manager of the Trust's Sterile Surgical Department said, "Using bar codes on individual surgical instruments not only enables the Trust to track instruments through the entire decontamination process but also link those instruments to a specific patient and any subsequent patients, which is vital for any 'look back' study involving 'high risk' category procedures."

"Furthermore, individual surgical instrument marking allows the Trust to identify staff training requirements and manage its inventory by giving the Trust a digital record of instrumentation in use. This information can then be monitored to demonstrate utilisation rates and trends of equipment use", he continued.

In October 2004, the NHS Purchasing and Supply Agency (PASA) recommended that all products supplied to the NHS should be identified using a bar code compliant with EAN.UCC standards, from GS1. "This has gone some way to furthering the uptake of an automated tracking and tracing system in the NHS," says Alaster Purchase, Healthcare Project Manager, GS1 UK. "However, the findings of the Patient's Association survey reveal there is still a long way to go and without full government backing the real concern is that we will never make the necessary progress."

Purchase continues, "The need for consistent, standards-compliant tracking is made all the more pressing by the imminent arrival of 'Super Centres', a network of offsite centres to which large quantities of equipment will be sent for decontamination. Without a formal tracking system, there is a danger that it will be impossible to effectively manage large numbers of instruments being sent offsite, risking instruments going missing and contaminated products being lost in the process."

"It is imperative that we are able to minimise the risk of instruments going missing and contaminated products being lost in the system by working with the Department of Health and hospitals to ensure that a coordinated approach to instrument tracking is put into place."

GS1 UK will be exhibiting at the Healthcare Computing event, stand number D24, from 21 - 23 March 2005 in Harrogate.

About GS1 UK
gs1uk.org

GS1 UK deploys and supports GS1 standards within the UK. It is part of the worldwide GS1 network which develops global supply chain standards and solutions used by over one million companies for bar coding, electronic business messaging, data synchronisation and, through the EPCglobal Network, radio frequency identification.

About the Patient's Association report
patients-association.com

The 2004 report "Tracking Medical Devices and the Implications for Patient Safety" was carried out with the support of GS1 UK. The report is a collaboration between the Patient's Association, the Institute of Decontamination Sciences (IDSc), the Infection Control Nurses Association (ICNA) and the National Association of Theatre Nurses (NATN). Results were compiled from the responses of 125 members of IDSc, ICNA and NATN during December 2004.